Rachael Alderson
Gans,PA
Summary
Clinical research professional with comprehensive expertise in study design, data analysis, and regulatory compliance. Strong collaborator, adaptable to changing needs, and reliable in achieving project outcomes. Expertise in protocol management, patient recruitment, and quality assurance, combined with results-driven mindset. Valued for analytical skills, effective communication, and problem-solving abilities.
Overview
14
14
years of professional experience
Work History
Clinical Research Specialist
West Virginia Clinical and Translational Science Institute
07.2022 - Current
- Develop, coordinate, and implement research and administrative strategies essential to the successful management of Phase II/III/IV clinical trials research conducted by faculty at West Virginia University Health Sciences Center
- Independently and collaboratively perform duties involved in clinical trial coordination and implementation, organization, oversight, documentation, tracking, data abstraction and collection and compilation of clinical research data
RN, Substance Abuse/ Mental Health
Valley HealthCare
10.2020 - 08.2022
- Per diem RN for the inpatient crisis unit
- Provide direct patient care to 8-12 patients in an inpatient Crisis Unit mostly geared towards medical detox from opiates, amphetamines, and/or alcohol
- Collaborate with therapists, counselors, and providers to provide best patient outcome
- Complete prior authorizations for medication and treatment
- Communicate with ER's across the state for referrals into our facility
- Help facilitate discharge planning by educating patients on medication, treatment, and outpatient expectations
RN, Surgical Oncology
WVU Medicine
09.2019 - 12.2020
- Full time RN on post-surgical oncology floor
- Provide direct patient care to 5/6 surgical oncology floor patients or 3 surgical oncology step-down patients
- Collaborate with physicians and ancillary staff
- Educate patients and family members on new medication, surgical incisions or other interventions (feeding tubes, PEG tubes, ostomies, trachs, laryngectomies)
Associate Manager (Quality Control Review and Release)
Mylan Pharmaceuticals
01.2015 - 12.2019
- Schedule releases of all Finished Product batches manufactured and packaged and the Morgantown facility
- Review analytical packets to ensure all data is within specification and the company's in house limits
- Lead a team 4-5 Release officers
- Participate in the ongoing company initiative of site scheduling to increase efficiency in all departments
- Communicate with supply chain through weekly meeting to ensure customer needs are being met
- Initiate/update SOPs and train others accordingly
Senior Chemist (Quality Control Operations)
Mylan Pharmaceuticals
11.2010 - 01.2015
- Conduct analytical testing of pharmaceutical products for compliance with in-house and USP specifications
- Evaluate and audit data and prepare technical and analytical reports
- Prepare and reviewed analytical investigation reports for determining the nature of aberrant test results and the disposition of finished product, intermediates, or API
- Lead a team of 4-5 analysts
- Help implement and execute a new scheduling system for the QC laboratory as part of a company initiative
- Schedule all Finished Product testing for the HPLC laboratory
Education
Associate - Nursing
Westmoreland County Community College
Youngwood, PA04.2019
B. S. - Biology
California University of Pennsylvania
05.2010
Skills
- Investigational product management
- Basic life support
- Clinical documentation
- Surgical Oncology Knowledge
- Staff management
- Teaching and mentoring
- Informed consent process
- Client confidentiality
- Strategic planning
- Collaborative research
- Clinical trial management
Nursing Licenses
- RN, 10/26, PA, RN723131
- RN, 10/26, WV, 104415
Timeline
Clinical Research Specialist
West Virginia Clinical and Translational Science Institute
07.2022 - Current
RN, Substance Abuse/ Mental Health
Valley HealthCare
10.2020 - 08.2022
RN, Surgical Oncology
WVU Medicine
09.2019 - 12.2020
Associate Manager (Quality Control Review and Release)
Mylan Pharmaceuticals
01.2015 - 12.2019
Senior Chemist (Quality Control Operations)
Mylan Pharmaceuticals
11.2010 - 01.2015
B. S. - Biology
California University of Pennsylvania
Associate - Nursing
Westmoreland County Community College
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